Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Colorado Medical, Inc. · Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

66 daysmedian FDA review time
128 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870471MODIFIED HR-3000 REUSE ADAPTORColorado Medical, Inc.1987-04-10660
K870689HR-3000 REUSE ADAPTORColorado Medical, Inc.1987-04-10500
K863471COLORADO MEDICAL MODEL PTC 1000Colorado Medical, Inc.1986-10-02230
K853735COLORADO MEDICAL MODEL CTM-3000Colorado Medical, Inc.1985-10-04280
K841153ADAPTOR HR-3000 REUSEColorado Medical, Inc.1984-07-161190
K830190AHR-3000 RE-USE ADAPTORColorado Medical, Inc.1983-05-271280

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda